The studies demonstrated once-monthly peginesatide, compared to epoetin alfa or epoetin beta dosed up to 13 times a month, maintained Hb levels in CKD patients on dialysis with anemia.
Affymax chief medical officer Anne-Marie Duliege said the peginesatide Phase 3 program was one of the most comprehensive clinical programs to support the initial submission of a new drug application (NDA) for an erythropoiesis stimulating agent (ESA).
"We believe these data analyses continue to support peginesatide as a potential agent to treat anemia in the dialysis patient population if approved," Duliege added.
Peginesatide is a synthetic, PEGylated peptidic compound which binds to and stimulates the erythropoietin receptor and thus acts as an ESA.